Sr. Quality Systems Engineer - CAPA

Sr. Quality Systems Engineer - CAPA Department: Quality Employment Type: Full Time Location: US-California-San Jose Compensation: $134,150 - $1,184,500 / year Description As a Sr. Quality Systems Engineer- CAPA, you will be responsible for maintaining and executing the Invisalign Multi-Site Corrective and Preventive Action (CAPA) process to ensure compliance with regulatory requirements and improve product quality and processes. You will also assist with training, documentation and change control processes. Role expectations Lead and manage the CAPA process, including investigation, root cause analysis, and implementation of corrective and preventive actions. Collaborate with cross-functional teams to identify and resolve quality issues. Develop and maintain CAPA documentation, ensuring accuracy and compliance with regulatory standards. Partner with global teams to provide an independent, technical review of CAPAs Monitor the effectiveness of CAPA actions and make necessary adjustments to ensure continuous improvement. Conduct regular CAPA reviews and audits to ensure compliance and effectiveness. Provide training and support to team members on CAPA processes and best practices. Prepare and present CAPA reports to management and regulatory bodies as required. Stay updated on industry regulations and standards related to CAPA and quality management. Report on status of CAPA system in alignment with site and corporate KPI’s Support harmonization of QMS elements following Global initiatives and incorporation of systems. Lead and support ongoing Quality Improvement projects and initiatives. What we're looking for Bachelor’s degree required Quality professional with minimum 8 years of experience - advantage in medical device industry At least 4 years of direct CAPA experience, owning CAPAs, performing, root cause analysis using a variety of problem solving methodologies, and ideally performing CAPA training. Experience in medical device and knowledge in ISO13485 & 21 CFR Part 820 Ability to organize information effectively, prioritizing tasks according to their urgency and importance. Ability to operate efficiently and effectively in a fast-paced environment Ability to work independently and lead end to end activities Strong written and verbal communication skills and teamwork skills Proficiency in Arena is an advantage Fluent in English, spoken and written Pay Transparency If provided, base salary or wage rate ranges are the range in which Align reasonably expects to set a candidate’s pay for the posted position. Actual placement depends on the individual skills and experience level of a candidate plus the total compensation and equity across team members. For other locations outside of the primary location, the base salary range will be adjusted geographically. For Field Sales roles, the salary listed is the base pay only and does not include the applicable incentive compensation plan. A cost of living adjustment may be added to base pay for higher cost areas in the U.S. Our internship hourly rates are a standard pay determined based on the position and your location, year in school, degree, and experience. General Description of All Benefits We are pleased to provide a general description of the benefits Align offers to full-time employees in this position. Family Benefits. Align offers employees and their eligible dependents medical (with a Health Savings Account option for some plan offerings), dental, and vision in accordance with those plans. Align also offers to employees: Discounts on Invisalign and Vivera to employees and their eligible dependents after 90 days of employment Back-up Child/Elder Care and access to a caregiving concierge Family Forming Benefits – Available to Employees, and their spouse or domestic partner, covered under one of Align’s health plans Breast Milk Delivery and Lactation Support Services Employee Assistance Program Hinge Health Virtual Physical Therapy – Available to all employees and eligible dependents (age 18+) enrolled in an Align medical Plan Employee benefits. Align offers its employees: Short-term and long-term disability insurance in accordance with those plans. Basic Life Insurance and Accidental Death and Dismemberment. Voluntary Supplemental Life Insurance for Employee, Spouse/Domestic Partner, and Child(ren) are available for purchase in accordance with those plans. Flexible Spending Accounts – Employees may be eligible to participate in a